The effects of herbal medicine (Jujadokseo-hwan) on quality of life in patients with mild cognitive impairment: Cost-effectiveness analysis alongside randomized controlled trial.

Background: Mild cognitive impairment (MCI), the early stage of dementia, requires effective intervention for symptom management and improving patients' quality of life (QoL). Jujadokseo-hwan (JDH) is a Korean herbal medicine prescription used to improve MCI symptoms, such as memory deficit. This study evaluates the improvement in QoL through JDH. Alongside a clinical trial, it estimates the cost-effectiveness of JDH, compared to placebo, for MCI over 24 weeks. Methods: Changes in QoL were measured using the EuroQol-5 Dimensions (EQ-5D) and Korean version QoL-Alzheimer's Disease (KQOL-AD). Direct medical and non-medical costs were surveyed and incremental cost-effectiveness ratios (ICER) per QALY for JDH were produced. Results: In total, 64 patients were included in the economic evaluation (n = 35 in JDH, n = 29 in placebo). In the JDH group, EQ-5D and KQOL-AD improved by 0.020 (p = .318) and 3.40 (p = .011) over 24 weeks, respectively. In the placebo group, they increased by 0.001 (p=.920) and 1.07 (p=.130), respectively. The ICER was KRW 76,400,000 per QALY and KRW 108,000 per KQOL-AD for JDH, compared to the placebo group. Conclusion: JDH is not considered a cost-effective treatment option compared with placebo; however, it positively affects QoL improvement in patients with MCI.

Investigation of combined treatment of acupuncture and neurofeedback for improving cognitive function in mild neurocognitive disorder: A randomized, assessor-blind, pilot study.

BACKGROUND: Mild neurocognitive disorder (MND) is an intermediate state that can progress to dementia, and the cognitive reserve of MND is an important task in preventing dementia. Acupuncture and neurofeedback (NF) training have been used to improve cognitive function and treat MND or dementia, but their effectiveness remains controversial. In this trial, we will evaluate the efficacy and safety of combined NF-acupuncture treatment in comparison with single acupuncture treatment. METHODS AND DESIGN: This study is a randomized, assessor-blind, pilot trial. It is designed in accordance with the Standards for Reporting Interventions in Controlled Trials of Acupuncture. A total of 44 MND participants who meet the inclusion and exclusion criteria will be enrolled, and each will be randomly assigned to 1 of 2 groups of 22 subjects. Each subject will visit 24 times over 12 weeks and receive either acupuncture or NF-acupuncture combined treatment. At visit 25 (week 13), a follow-up evaluation will be performed, and then the investigator will analyze the results. The primary outcome is defined by the Korean version of the Montreal Cognitive Assessment score from screening to visit 25. The secondary outcome includes the following: change in Alzheimer Disease Assessment Scale-Cognitive, the Korean version of the Beck Depression Inventory, Body Awareness Questionnaire, delayed matching to sample task scores, and functional near-infrared spectroscopy values, from visit 1 to visit 25; heart rate variability values from visit 1 to visit 5, visit 9, visit 13, visit 21, visit 25; breath per minute values from visit 1 to visit 1 to 25. DISCUSSION: We will evaluate the effectiveness and safety of combined NF-acupuncture therapy, and expect that it will serve as the basis for the use of NF together with acupuncture in the clinical setting. TRIAL REGISTRATION NUMBER: KCT0004972 (registered in Clinical Research Information Service of the Republic of Korea, https://cris.nih.go.kr/cris/search/detailSearch.do/16239).

Corrigendum to "Acupuncture using pattern-identification for the treatment of insomnia disorder: a systematic review and meta-analysis of randomized controlled trials" [Integr Med Res 8 (2019) 216-226].

[This corrects the article DOI: 10.1016/j.imr.2019.08.002.].

Safety and efficacy of Jujadokseo-hwan for memory deficit (amnesia) in mild neurocognitive disorder: A protocol for randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical trial.

BACKGROUND: Mild neurocognitive disorder (mNCD) is one of the degenerative diseases that results in memory deficit, and can progress to dementia. The effectiveness of drug therapy for mNCD is still debatable, but treatment of this disease has important implications for postponing or preventing dementia. Jujadokseo-hwan (JDH) is a traditional herbal medicine formulation that exhibits improvement in cognitive abilities and neuroprotective effects. In this study, we will evaluate the safety and efficacy of JDH compared to placebo in mNCD patients. METHODS AND DESIGN: This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical trial. After obtaining informed consent from all participants and performing the screening process, the participants will be equally divided into an experimental group and a control group. Each participant will visit the trial center 7 times during the 12 weeks of intervention. The follow up study will be conducted 12 weeks after the intervention ends. The primary outcome is the variance in Seoul verbal learning test-elderly's version (SVLT-E) score from baseline to 12 weeks. Secondary outcomes include scores/values for the following variables: SVLT-E, Rey complex figure test, Digit span test, Korean-Boston naming test, calculation ability, controlled oral word association test, Korean-color word stroop test, digit symbol coding, Korean-trail making test-elderly's version, Korean version of mini mental state examination for dementia screening, euro-qol-5 dimension, pattern identifications tool for cognitive disorders, Korean version of Montreal cognitive assessment, Korean quality of life-Alzheimer disease, computerized tongue image analysis system, blood pressure pulse analyzer, bioelectrical impedance analyzer, wearable electroencephalogram device, functional near-infrared spectroscopy system, and cost analysis. DISCUSSION: This is the first trial evaluating the efficacy of JDH for mNCD. We expect this trial will provide strong support for wide use of JDH for mNCD and lead to further research on herbal medicine treatments for mNCD. TRIAL REGISTRATION NUMBER: KCT0003570 (Registered in Clinical Research Information Service of the Republic of Korea, https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=12669).

Acupuncture using pattern-identification for the treatment of insomnia disorder: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Insomnia symptoms are common, affecting almost 30% of the population of the population. Many use medications that may be ineffective and cause substantial harm. In complementary and alternative medicine, acupuncture is widely used to manage mental health problems. Acupuncture therapy emphasizes individualized treatment according to TCM pattern diagnosis. Although there are some systematic reviews that acupuncture has the benefit for insomnia, there is no systematic review on acupuncture using pattern identification. This review aimed for evaluating acupuncture efficacy using pattern-identification to treat insomnia. METHODS: We carried out a comprehensive review of randomized controlled trials (from 2000 to April 12, 2018), using PubMed, Cochrane CENTRAL, EMBASE, CINAHL, PsycINFO, CNKI, and 3 Korean (OASIS, NDSL, RISS4U) databases, comparing acupuncture using pattern identification (only) with medication in primary insomnia. Response rate and the Pittsburgh Sleep Quality Index (PSQI) were the primary outcomes. Risk of bias and publication biases were evaluated, and meta-analyses were conducted. RESULTS: Nineteen RCTs were included (11 manual acupuncture (1079 patients), 8 electro-acupuncture (442 patients)) of low quality. Meta-analyses of all studies reveled that acupuncture improved total effectiveness rate (Risk Ratio [RR] = 1.23, 95% confidence intervals [CIs]: 1.12-1.35, p < 0.00001; I2 = 80%) and PSQI (MD = -1.92, 95% CI: -2.41-1.42, p < 0.00001; I2 = 30%) compared to medication. Results of overall risk of bias assessments were unclear or high. CONCLUSIONS: Acupuncture using pattern identification led to significantly improved total effectiveness rate compared to medication. With regard to PSQI, as compared to the control group, acupuncture using pattern identification was similar to medication. However, this study has limitations of high risk of bias, not using a standardized pattern-diagnosis-treatment and not comparing with standarized acupuncture without pattern identification.

The Pilot Survey of the Perception on the Practice Pattern, Diagnosis, and Treatment on Korean Medicine Insomnia: Focusing on the Difference between Korean Medical Neuropsychiatry Specialists and Korean Medical General Practitioners.

INTRODUCTION: This study aims to investigate the clinical practice states on the diagnosis and treatment for insomnia between Korean medical general practitioners (KMGPs) and Korean medical neuropsychiatry specialists (KMNPSs). METHODS: We distributed questionnaires via email or in person to 1,017 KMGPs and via email to 165 KMNPSs. We collected and analyzed responses from 305 (30.00%) KMGPs and 53 (32.12%) KMNPSs. RESULTS: Most KMGPs and KMNPSs responded that the number of new patients visiting the clinic for treatment of insomnia was less than 10 per month (78.2%). Frequently utilized therapies for insomnia are acupuncture and herbal decoctions. Particularly acupoint GV20 and Guipi decoction were chosen with the highest response rate. There was no difference between KMNPSs and KMGPs in the traditional Korean medical diagnosis methods. However, KMNPSs utilized more various methods to diagnose, treat, and evaluate insomnia and educated more actively sleep hygiene compared to KMGPs. CONCLUSIONS: This survey showed how insomnia is currently diagnosed and treated in Korean medical care settings. Moreover, we identified some differences between KMNPSs and KMGPs. Further research is required to explore the underlying reasons for these discrepancies among KMDs and to improve the quality of Korean medical clinical practice in treating insomnia.